Septal puncture is utilized in patients in which a communication is present between the two atria of the heart, for example, a patient with a patent foramen ovale (PFO). A PFO consists of two layers of overlapping but unfused tissues, the septum primum and the septum secundum, forming a tunnel like “hole” between the two tissues that can put the patient at a high risk of embolic stroke. Due to the tunnel-like nature of many PFOs, an occlusion device that is used to repair the PFO often does not sit flat on the septal wall when it is implanted, such that a portion of the occluder is positioned in the PFO tunnel. For this reason a second hole in the septum primum part of the atrial septum near the PFO is introduced by septal puncture through which the occlusion device is then positioned (rather than through the PFO tunnel).
Septal puncture through an intact atrial septum from the right atrium to the left atrium is also often necessary. This is traditionally performed using rigid, long needles, such as Brockenbrough or Ross needles. In all types of septal puncture, the needle that is used to puncture the atrial septum poses a high risk of inadvertent puncture through tissue other than the septum primum, for example, the atrial free wall, posing a significant risk to the patient. For PFO closure, this risk is potentially even higher, due to the fact that the septal tissue is defective and often thinning, and may stretch an even greater amount during the puncture procedure, bringing the tip of the needle dangerously close to the atrial free wall or the left atrial appendage.
A device and method that permits the surgeon to safely puncture both an intact atrial septum and an atrial septum having a PFO is therefore needed.